Making Sense of the IOM Controversy

Health and Human Services’ (HHS) decision to entrust the new definition of ME and CFS to the Institute of Medicine (IOM) has generated a firestorm of controversy, dividing members of the ME/CFS community into three camps: pro, con and confused.

With the CFIDS Association of America’s endorsement of the IOM contract,1 and Dr. Bateman's subsequent shift of position, 2 the two opposing camps have become increasingly contentious, while the third is suffering from acronym overload.

Most people with ME/CFS prefer to avoid conflict at all costs, so this division generates, if not an outright headache, something akin to an emotional migraine. Even if we want to be kept informed, after a while the discussion blurs into a dense fog of shifting accusations and counter-accusations that we simply cannot absorb.

There is a strong temptation to simply ignore it all, and let the chips fall where they may. After all, this is not the first time the CFS/ME community has been divided, and it won’t be the last. In any case, a new definition won’t change the realities of the illness... Or will it?

Why is the case definition important?

As far as research, diagnosis, and treatment are concerned, nothing is more important than a case definition. For researchers, a case definition is used to establish a patient cohort. If a definition is too open-ended, researchers may end up including people who do not have the illness they are studying, thus invalidating their results. For physicians, a case definition is used to diagnose patients, which will then, hopefully, lead to appropriate treatment.

The current case definition of CFS in the United States, the “Fukuda” definition (named for its first author) fails on all of these counts. It was developed in 1994 by a group that included a roster of physicians with highly disparate orientations – from Steven Strauss, Michael Sharpe and Simon Wessely, who believed that the illness they were defining was a psychiatric disorder, to Anthony Komaroff and Dan Peterson, who knew it wasn’t. The diverse backgrounds of these authors, some of whom had no direct clinical experience with the illness, made for a definition that was, like the ungainly camel, “designed by a committee.” By the time this group was ready to publish the new definition, consensus still had not been reached. 3

In the end, a broad definition of CFS was adopted, leading, as many suspected it would, to problems establishing patient cohorts for research, inaccurate diagnoses, and a widespread belief among the general public and most physicians that the illness could be equated with “tiredness.” Nineteen years later, after pressure from patients and the professional community, as well as the CFSAC, the “Fukuda” definition was finally recognized as inadequate by the federal government.

The development of an accurate case definition

The primary sticking point in the Fukuda case definition is that Post-Exertion Malaise (PEM) is optional, which means patients with major depression - as well as patients with early MS, some forms of leukemia, genetic disorders, incipient heart disease, Hashimoto’s disease, diabetes, and numerous other ailments that a CBC might have missed – may be included. This is a disaster not just for researchers who don’t have a reliable means of establishing a patient cohort (and for patients who end up waiting years for a diagnosis), but for thousands of patients who don’t have CFS. These patients often have illnesses such as early MS (which presents as fatigue), Hashimoto’s disease (which causes profound exhaustion, and does not show up on standard lab results until it is advanced), or any one of the myriad other illnesses that begin with fatigue. Because a diagnosis of CFS often produces an admonition to exercise, and perhaps a prescription for antidepressants, for these patients, “CFS” can be fatal.

The numerous shortcomings of the Fukuda definition motivated a group of experienced clinicians and researchers to devise their own. This was the Canadian Consensus Criteria (CCC), which was published in the Journal of Chronic Fatigue Syndrome in2003. 4 In sharp contrast to the Fukuda definition, the CCC requires PEM, as well as neurological, neurocognitive, neuroendocrine, dysautonomic, circulatory, and immune symptoms.

Over the past ten years, researchers who are serious about establishing reliable cohorts have employed the CCC. Clinical ME/CFS specialists also prefer the CCC, finding it to be more accurate for making a diagnosis. (According to a 2011 study led by Leonard Jason, the CDC “Fukuda” criteria only identified 79% of patients with CFS/ME, while the CCC identified 87%). 5 But while the CCC has been used for a decade by serious researchers and clinicians, it is not entirely surprising that the federal government has been slow on the uptake. Federal funding for CFS has been minimal at best, creating minimal interest in the illness on all levels.

The IOM contract – from suspicion to dread

True to form, the federal government decided that rather than adopt a case definition that had been created and successfully used by experts, they would rather reinvent the wheel. On August 28th, HHS announced that it intended to hire the Institute of Medicine (IOM) to formulate a new case definition for CFS. This raised the suspicions of ME/CFS advocates both for the timing of the announcement (right before Labor Day), and for the speed with which HHS intended to assign the contract. (After 19 years, why the sudden rush?)

Suspicions were further confirmed when it was discovered that the IOM not only had little experience in defining illnesses, but that their previous definition of Gulf War Illness as “chronic multi-symptom illness” had met with universal criticism from GWI patients, clinicians and researchers. “Chronic multi-symptom illness,” as GWI advocates correctly pointed out, could describe just about any long-term illness. In effect, Gulf War Illness had been “undefined.” What was more, the IOM’s recommended treatments for “CMI” consisted of antidepressants and cognitive behavioral therapy.6 There was every indication that CFS was going to suffer the same fate.

Patients and advocates immediately began bombarding HHS Secretary Kathleen Sebelius with letters. It appeared as if the IOM contract had been halted when HHS issued a statement that it was no longer going to pursue its solicitation of the IOM, a statement which was almost immediately revoked when it turned around and hired IOM on September 23rd.

The response was instantaneous. The same day that HHS announced it was going forward with the contract, a letter signed by 35 top ME/CFS physicians both in the US and abroad was sent to Secretary Sebelius requesting that HHS drop the IOM contract, and asking for the immediate adoption of the CCC. Within the month, 16 more experts had signed the letter, bringing the total to 50. 7

One would think that with such an unequivocal statement from the leading researchers and clinicians in the field that HHS would take notice. More to the point, one would think that the ME/CFS community itself would rally around such an unprecedented move. And, to a large extent it did, with letters of support coming from the National Alliance for ME (NAME), Dr. Lily Chu, and Dr. Eleanor Stein, and no fewer than three petitions. There was, however, one notable exception to this outpouring of approval.

Fifth columnists

The CFIDS Association of America, the largest ME/CFS non-profit in the country, against all apparent logic, decided to endorse the IOM contract. There appeared to be no solid reason for the endorsement other than the hope that the IOM contract would “open federal doors.” In marked contrast to the position taken by nearly all the experts in the field, the CAA came to the conclusion that the IOM contract would be an “opportunity” rather than a debacle.

To bolster what was undoubtedly going to be an unpopular position, the CAA sent an email to all the experts who had signed the letter, asking them (indirectly) to reverse their position. One signatory, Dr. Lucinda Bateman, did so, citing the reasons that had been put forth by the CAA. (Dr. Bateman serves on the CAA’s Research Advisory Council.) One ME/CFS advocacy organization, PANDORA, also published an endorsement of the IOM contract, using much the same language.

Drawing fire

As might be predicted, the reaction to the CAA’s ill-disguised attempt to persuade the experts to rescind their signatures came swiftly. Dr. Mikovits responded with a tart rejoinder:

“I know that the CAA is not and has never in my experience responded to concerns expressed by the patients, nor do they now or have they ever served in the best interests of the patients, as is the only duty of an advocacy organization. This IOM contract is simply a waste of precious resources. I stand by my signature on the letter and my work which is now always has been and will always be in the best interests of the patients.” 8

Advocates suggested that a conflict of interests might be involved. Suzanne Vernon, scientific director of the CAA, is on the IOM panel that defined Gulf War Illness as “chronic multi-symptom illness.” Critics pointed out that the CAA had benefited from its long association with government agencies, and might continue to do so because of its role in the IOM contract. (The CAA earned over $8 million in government grants during 2000-2007. As of 2008, government grants ceased to be a line item on IRS forms for non-profits.)

This wave of criticism prompted a response (originally posted without a signature) from Suzanne Vernon, in which she attempted to “clear the air.” 9 Her effort at setting the record straight was greeted with skepticism, if not outright derision.

PANDORA’s endorsement of the IOM contract met with much the same reaction. PANDORA's statement that it would “do all [it] can to avoid an IOM definition disaster…" was characterized as delusional. 10 And PANDORA's assurance that the IOM would be open to ME/CFS experts who "have the experience and knowledge to define the disease" and that “any effort to update the definition should start with the 2003 CCC” was judged to be either "naïve or co-opted." *

Shortly after PANDORA issued its statement, a group of 60 patient forum leaders, not-for-profit organization managers, scholars, authors, filmmakers, bloggers and other advocates signed a letter addressed to Secretary Sebelius, voicing their support for experts' letter.

You can’t get there from here

Like the punchline of an old joke, the real question is whether we can get there from here. Can the IOM contract really open doors? Will HHS adopt a precise definition of ME/CFS that requires the hallmark symptom of PEM? Will the experts on the IOM panel be real experts, rather than people who happen to have connections with the IOM? Can the ME/CFS community exert its influence to make sure the IOM definition is conducive to better research, diagnosis and treatment?

These are big questions, and the answer to all of them is "no."

History has shown us that we cannot change HHS "from within." Government institutions have a vested interest in maintaining the staus quo for the simple reason that advancement within those institutions is predicated on not rocking the boat. Independent thinking, especially when it contradicts the received wisdom of people higher up in the chain of command, is actively discouraged in government service. In the case of ME/CFS, the status quo is comprised of lack of funding for ME/CFS research, a dismissive attitude towards the illness (couched in kinder, gentler "discussions"), the obstruction of the approval of drugs which might actually be of benefit to the sickest members of our community (Ampligen), and the perpetuation of the myth that the illness is fundamentally psychogenic and can be mitigated through therapy and exercise.

There is a lot at stake here, much more than meets the eye. So, regardless of the “friendly fire,” online arguments, and heated exchanges coming out of this battle, it is absolutely essential that members of the ME/CFS community stay clear and rational.

A redefinition of CFS as “chronic multi-symptom illness,” or any other meaningless concatenation, will not improve upon the current definition, it will not lead to effective treatment, it will not increase funding for research, and it will not lead to acceptance by the medical community. Instead, it will usher in the widespread dismissal of ME/CFS as an organic illness, and cause a halt in meaningful research. As the experts have rightly pointed out, “this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable. ME/CFS patients who have been disabled for decades by this devastating disease need to see the field move forward and there is no time to waste.”

In a nutshell

Hillary Johnson and other knowledgeable advocates have observed that over the past 30 years the government agencies entrusted with our welfare have repeatedly done everything in their power to relegate CFS to the dustbin of psycho-social illness. There is no indication that HHS has made any change in this long-standing policy. Johnson's advice on this matter is: Nocooperation, only resistance.

Fifty of the world’s leading experts in the field of ME/CFS treatment and research have categorically rejected the IOM contract, and have endorsed the CCC as the sole definition for ME/CFS.

There is at present a world-wide effort to officially, and permanently, categorize ME and CFS as psychological illnesses. The IOM contract is part of that effort.11

The ME/CFS community is not divided on the issue of the IOM contract. Thousands of people have signed the petition to revoke the IOM contract, as well as the thank you petition to our experts, and the petition to adopt the CCC. Only two organizations have backed the IOM contract, the CAA and PANDORA. The majority of our ME/CFS organizations have not.

* It should be noted that not all members of PANDORA's board support the IOM contract.

Erica Verrillo is the author of Chronic Fatigue Syndrome: A Treatment Guide, 2nd Edition, available as an electronic book on Amazon, Barnes & Noble, Kobo and Payhip (PDF file). Her website,CFSTreatmentGuide.com, provides practical resources for patients with ME/CFS. She also maintains a blog, Onward Through the Fog, with up-to-date news and information about the illness, as well as the full text of CFS: A Treatment Guide, 1st Edition (available in translation). Ms. Verrillo has been the editor of ProHealth's ME/CFS and Natural Wellness HealthWatch newsletters since February 2013.

Erica thanks so much for this well written summary of the events surrounding the IOM Controversy. I did not even realize that there were two petitions available to sign related to this controversy. Yes, I have been a bit overwhelmed and confused by the sheer volume of information this controversy has raised. However, I thank you and other patient advocates who are able to so articulately communicate very legitimate concerns with this contract and the current ME/CFS definition.

I would strongly encourage patients, family members and friends to consider signing both of these petitions (available on-line) to express your concerns as well. The more voices who are willing to speak up, even if just adding a name to an on-line petition, can have a significant impact on making us visible to the world by allowing the sheer mass of our numbers to be both seen and heard.

As has also been linked in this article, here is where you can sign up to be included in these two petitions.

Thank you for this great article, Erica. I certainly agree with you that this contract is a disaster and MUST be stopped.

I don't mean to be nitpicky, but there were some small mistakes I spotted:
- Suzanne Vernon was not on the last IoM GWI committee, she is on the current one to redefine GWI.
- NAAME did not publicly oppose the contract, but NAME, with one A did. I have no idea why NAAME chose its name, since it can so easily be confused with NAME, the National Association for ME.
- Lucinda Bateman is no longer on CAA's Scientific Advisory Board, which has changed it's name to the Research Advisory Council. This confusion is the fault of CAA, since it published this update on its Research1st blog in August, but still has not updated its website- Lucinda Bateman still appears on the website.

http://www.research1st.com/2013/08/20/research-advisory-council/

This next one isn't a mistake, but I disagree with you about PANDORAs position, it has not really endorsed the IoM contract, but it has said some bad stuff imo (along with some good stuff) about the IoM contract and could have been a lot clearer that it opposes the contract. It's position statements are very wordy and for the first one you have to infer that it strongly opposes the contract and in the second one, its opposition is stated weakly, imo. PANDORAs advocacy on this has been too tepid as usual. It needs to aggressively and very clearly and concisely oppose the contract.

As for PANDORA's position, after reading their statement, I can't understand it. Sitting on the fence simply isn't possible with this issue, and it appears that is exactly what they are doing. They appear to be saying, "If life hands you lemons, make lemonade." In other words, if the contract can't be stopped, make the best of it. (This also underlies Bateman's position.)

In reality, the contract can indeed be canceled. And there is absolutely no way that HHS will allow us to make lemonade. IOM will do exactly what FDA did, "We feel your pain, now on to our agenda."

This is a very well written article. It explains clearly and thoroughly what all the noise has been about. I'm appalled at how experts in this disease can be so easily dismissed just so that a government organization can pursue their own agenda.

There has to be some way to put a stop to this! As you pointed out, there are people being put at significant risk because they are erroneously being diagnosed with ME/CFS. Then, there are people who spend years before being diagnosed - years that could have been spent in proper treatment, instead of being told "it's all in your head".

ME/CFS patients are often too sick to fight the good fight. However, having a clear understanding of the facts means I don't have to waste hours, days, weeks or even months trying to figure it all out on my own. Thanks to the work you have done, I know how I can add my voice to the fight.